Events

Recall of Device Recall SIEMENS ARTISTE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65435
  • Event Risk Class
    Class 2
  • Event Number
    Z-1562-2013
  • Event Initiated Date
    2013-05-29
  • Event Date Posted
    2013-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118888
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    The potential for a safety issue, for the image quality degradation, that is addressed by the customer safety advisory notice when verifying the patient position based on 2d images that were acquired as single-exposure mv or in-line kview images using the syngo rt therapist 4.3.
  • Action
    Siemens sent an Urgent: Medical Device Correction Customer Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem, what preventive measures can the user take and actions to be taken. Customers were advised to perform the preventive measures provided and inform all affected personnel immediately. The letter states that Siemens is currently working on a new version of the software. Customers are asked to include the Customer Safety Advisory Notice in the System Owner Manual chapter "Safety Advisory Letters". For question call 925-602-8157.

Device

Device Recall SIEMENS ARTISTE
  • Model / Serial
    All units of the version 4.3, Part No. 08162815
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    ARTISTE with syngo RT Therapist version 4.3 || Product Usage: || The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 757 Arnold Dr Ste A, Martinez CA 94553-3615
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA